MD
Maryland House Bill HB571

Maryland 2023 Regular Session

Maryland House Bill HB571 Compare Versions

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1- WES MOORE, Governor Ch. 356
21
3-– 1 –
4-Chapter 356
5-(House Bill 571)
62
7-AN ACT concerning
3+EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
4+ [Brackets] indicate matter deleted from existing law.
5+ Underlining indicates amendments to bill.
6+ Strike out indicates matter stricken from the bill by amendment or deleted from the law by
7+amendment.
8+ Italics indicate opposite chamber/conference committee amendments.
9+ *hb0571*
810
9-Overdose Response Program – Opioid Overdose Reversal Drugs – Choice of
10-Formulation and Dosage
11-Opioids – Opioid Restitution Advisory Council and Fund and Overdose
12-Response Program
11+HOUSE BILL 571
12+J1 (3lr1931)
13+ENROLLED BILL
14+— Health and Government Operations/Finance —
15+Introduced by Delegate Kipke Delegates Kipke, Alston, Bagnall, Bhandari,
16+Chisholm, Cullison, Guzzone, Hill, S. Johnson, Kaiser, Kerr, R. Lewis,
17+Lopez, Martinez, M. Morgan, Pena–Melnyk, Rosenberg, Szeliga, Taveras,
18+White, and Woods
1319
14-FOR the purpose of authorizing the Attorney General to direct that an Opioid Restitution
15-Fund Advisory Council committee be formed if required by a court or administrative
16-order or settlement agreement entered into by the Attorney General; requiring the
17-Maryland Department of Health, subject to the limitations of the State budget, to
18-allow certain entities provided opioid overdose reversal drugs by the Department
19-under the Overdose Response Program to choose the formulation or dosage of opioid
20-overdose reversal drugs approved by the federal Food and Drug Administration with
21-which the entity is to be provided; applying the requirement that the appropriation
22-and distribution of funds in the Opioid Restitution Fund that were received in
23-accordance with certain opioid–related final distributor and settlement agreements
24-be made in a certain manner to funds received in accordance with any opioid–related
25-court or administrative judgment or settlement agreement; and generally relating to
26-the Overdose Response Program opioids.
20+Read and Examined by Proofreaders:
2721
28-BY repealing and reenacting, with amendments,
29- Article – Health – General
30-Section 7.5–903(f), 7.5–904, and 13–3103
31- Annotated Code of Maryland
32- (2019 Replacement Volume and 2022 Supplement)
22+_______________________________________________
23+Proofreader.
24+_______________________________________________
25+Proofreader.
3326
34-BY repealing and reenacting, without amendments,
35- Article – State Finance and Procurement
36- Section 7–331(a) through (c)
37- Annotated Code of Maryland
38- (2021 Replacement Volume and 2022 Supplement)
27+Sealed with the Great Seal and presented to the Governor, for his approval this
3928
40-BY repealing and reenacting, with amendments,
41- Article – State Finance and Procurement
42- Section 7–331(h)
43- Annotated Code of Maryland
44- (2021 Replacement Volume and 2022 Supplement)
29+_______ day of _______________ at ________________________ o’clock, ________M.
4530
46- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
47-That the Laws of Maryland read as follows:
31+______________________________________________
32+Speaker.
4833
49-Article – Health – General Ch. 356 2023 LAWS OF MARYLAND
34+CHAPTER ______
5035
51-– 2 –
36+AN ACT concerning 1
5237
53-7.5–903.
38+Overdose Response Program – Opioid Overdose Reversal Drugs – Choice of 2
39+Formulation and Dosage 3
40+Opioids – Opioid Restitution Advisory Council and Fund and Overdose 4
41+Response Program 5
5442
55- (f) [With] SUBJECT TO § 7.5–904(C) OF THIS SUBTITLE , WITH the consent of
56-the Council, the chair may designate additional individuals with relevant expertise to serve
57-on a committee of the Council in an advisory capacity.
43+FOR the purpose of authorizing the Attorney General to direct that an Opioid Restitution 6
44+Fund Advisory Council committee be formed if required by a court or administrative 7
45+order or settlement agreement entered into by the Attorney General; requiring the 8
46+Maryland Department of Health, subject to the limitations of the State budget, to 9
47+allow certain entities provided opioid overdose reversal drugs by the Department 10
48+under the Overdose Response Program to choose the formulation or dosage of opioid 11
49+overdose reversal drugs approved by the federal Food and Drug Administration with 12 2 HOUSE BILL 571
5850
59-7.5–904.
6051
61- (a) (1) [The] SUBJECT TO SUBSECTION (C) OF THIS SECTION, THE Council
62-may adopt procedures necessary to do business, including the creation of committees.
52+which the entity is to be provided; applying the requirement that the appropriation 1
53+and distribution of funds in the Opioid Restitution Fund that were received in 2
54+accordance with certain opioid–related final distributor and settlement agreements 3
55+be made in a certain manner to funds received in accordance with any opioid–related 4
56+court or administrative judgment or settlement agreement; and generally relating to 5
57+the Overdose Response Program opioids. 6
6358
64- (2) The Council may consult with State agencies to carry out the duties of
65-the Council.
59+BY repealing and reenacting, with amendments, 7
60+ Article – Health – General 8
61+Section 7.5–903(f), 7.5–904, and 13–3103 9
62+ Annotated Code of Maryland 10
63+ (2019 Replacement Volume and 2022 Supplement) 11
6664
67- (3) The Council shall meet at least four times a year.
65+BY repealing and reenacting, without amendments, 12
66+ Article – State Finance and Procurement 13
67+ Section 7–331(a) through (c) 14
68+ Annotated Code of Maryland 15
69+ (2021 Replacement Volume and 2022 Supplement) 16
6870
69- (4) A majority of the voting members of the Council is a quorum.
71+BY repealing and reenacting, with amendments, 17
72+ Article – State Finance and Procurement 18
73+ Section 7–331(h) 19
74+ Annotated Code of Maryland 20
75+ (2021 Replacement Volume and 2022 Supplement) 21
7076
71- (b) The Opioid Operational Command Center shall provide appropriate staff
72-necessary to support the functions of the Council.
77+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 22
78+That the Laws of Maryland read as follows: 23
7379
74- (C) (1) IF REQUIRED BY A COURT O R ADMINISTRATIVE ORD ER OR A
75-SETTLEMENT AGREEMENT ENTERED INTO BY THE ATTORNEY GENERAL, THE
76-ATTORNEY GENERAL MAY DIRECT TH AT A COUNCIL COMMITTEE BE FORMED IN
77-ACCORDANCE WITH THE REQUIREMENTS OF THE COURT OR ADMINISTRAT IVE
78-ORDER OR SETTLE MENT AGREEMENT .
80+Article – Health – General 24
7981
80- (2) THE ATTORNEY GENERAL SHALL ESTABLI SH PROCEDURES FOR A
81-COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS SUBSECTION I N ORDER TO
82-ENSURE COMPLIANCE WI TH THE REQUIREMENTS OF THE COURT OR
83-ADMINISTRATIVE ORDER OR SETTLEMENT AGREEM ENT.
82+7.5–903. 25
8483
85- (3) (I) SUBJECT TO SUBPARAGRA PH (II) OF THIS PARAGRAPH , A
86-COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS SUBSECTION S HALL CONDUCT
87-ONLY BUSINESS RELATE D TO THE PURPOSE OF THE COURT OR ADMINIS TRATIVE
88-ORDER OR SETTLEMENT AGREEMENT THAT REQUI RED THE FORMATION OF THE
89-SUBCOMMITTEE .
84+ (f) [With] SUBJECT TO § 7.5–904(C) OF THIS SUBTITLE , WITH the consent of 26
85+the Council, the chair may designate additional individuals with relevant expertise to serve 27
86+on a committee of the Council in an advisory capacity. 28
9087
91- (II) A COMMITTEE MAY CONDUC T BUSINESS RELATED T O
92-MULTIPLE COURT OR AD MINISTRATIVE ORDERS OR SETTLEMENT AGREEM ENTS IF
93-THE COURT OR ADMINIS TRATIVE ORDERS OR SE TTLEMENT AGREEMENTS CONTAIN
94-IDENTICAL REQUIREMEN TS.
95- WES MOORE, Governor Ch. 356
88+7.5–904. 29
9689
97-– 3 –
98- (4) A COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS
99-SUBSECTION MAY CONSI ST ONLY OF MEMBERS O F THE COUNCIL.
90+ (a) (1) [The] SUBJECT TO SUBSECTION (C) OF THIS SECTION, THE Council 30
91+may adopt procedures necessary to do business, including the creation of committees. 31
10092
101- (5) UNLESS OTHERWISE PROV IDED IN A COURT OR A DMINISTRATIVE
102-ORDER OR SETTLEMENT AGREEMENT , THE CHAIR OF THE COUNCIL, OR THE CHAIR’S
103-DESIGNEE, SHALL BE CHAIR OF A COMMITTEE FOR MED UNDER PARAGRAPH (1) OF
104-THIS SUBSECTION .
93+ (2) The Council may consult with State agencies to carry out the duties of 32
94+the Council. 33
10595
106-13–3103.
96+ (3) The Council shall meet at least four times a year. 34
10797
108- (a) The Department shall adopt regulations necessary for the administration of
109-the Program.
98+ (4) A majority of the voting members of the Council is a quorum. 35 HOUSE BILL 571 3
11099
111- (b) The Department may:
112100
113- (1) Collect fees necessary for the administration of the Program;
114101
115- (2) Authorize private or public entities to conduct education and training
116-on opioid overdose recognition and response that include:
102+ (b) The Opioid Operational Command Center shall provide appropriate staff 1
103+necessary to support the functions of the Council. 2
117104
118- (i) Education on recognizing the signs and symptoms of an opioid
119-overdose;
105+ (C) (1) IF REQUIRED BY A COURT OR ADMINISTRAT IVE ORDER OR A 3
106+SETTLEMENT AGREEMENT ENTERED INTO BY THE ATTORNEY GENERAL, THE 4
107+ATTORNEY GENERAL MAY DIRECT TH AT A COUNCIL COMMITTEE BE FORMED IN 5
108+ACCORDANCE WITH THE REQUIREMENTS OF THE COURT OR ADMINISTRAT IVE 6
109+ORDER OR SETTLEMENT AGREEMEN T. 7
120110
121- (ii) Training on responding to an opioid overdose, including the
122-administration of opioid overdose reversal drugs approved by the federal Food and Drug
123-Administration; and
111+ (2) THE ATTORNEY GENERAL SHALL ESTABLI SH PROCEDURES FOR A 8
112+COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS SUBSECTION I N ORDER TO 9
113+ENSURE COMPLIANCE WI TH THE REQUIREMENTS OF THE COURT OR 10
114+ADMINISTRATIVE ORDER OR SETTLEMENT AGREEM ENT. 11
124115
125- (iii) Access to opioid overdose reversal drugs approved by the federal
126-Food and Drug Administration and the necessary supplies for the administration of the
127-opioid overdose reversal drugs;
116+ (3) (I) SUBJECT TO SUBPARAGRAPH (II) OF THIS PARAGRAPH , A 12
117+COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS SUBSECTION S HALL CONDUCT 13
118+ONLY BUSINESS RELATE D TO THE PURPOSE OF THE COURT OR ADMINIS TRATIVE 14
119+ORDER OR SETTLEMENT AGREEMENT THAT REQUI RED THE FORMATION OF THE 15
120+SUBCOMMITTEE . 16
128121
129- (3) Develop guidance regarding the content of educational training
130-programs conducted by private or public entities; and
122+ (II) A COMMITTEE MAY CONDUC T BUSINESS RELATED T O 17
123+MULTIPLE COURT OR AD MINISTRATIVE ORDERS OR SETTLEMENT AGREEM ENTS IF 18
124+THE COURT OR ADMINIS TRATIVE ORDERS OR SE TTLEMENT AGREEMENTS CONTAIN 19
125+IDENTICAL REQUIREMEN TS. 20
131126
132- (4) Collect and report data on the operation and results of the programs.
127+ (4) A COMMITTEE FORMED UND ER PARAGRAPH (1) OF THIS 21
128+SUBSECTION MAY CONSI ST ONLY OF MEMBERS O F THE COUNCIL. 22
133129
134- (c) An individual is not required to obtain training and education on opioid
135-overdose recognition and response from a private or public entity under subsection (b) of
136-this section in order for a pharmacist to dispense an opioid overdose reversal drug approved
137-by the federal Food and Drug Administration to the individual.
130+ (5) UNLESS OTHERWISE PROV IDED IN A COURT OR A DMINISTRATIVE 23
131+ORDER OR SETTLEMENT AGREEMENT , THE CHAIR OF THE COUNCIL, OR THE CHAIR’S 24
132+DESIGNEE, SHALL BE CHAIR OF A COMMITTEE FORMED UND ER PARAGRAPH (1) OF 25
133+THIS SUBSECTION . 26
138134
139- (d) (1) Subject to the limitations of the State budget, the Department shall
140-purchase and provide opioid overdose reversal drugs approved by the federal Food and
141-Drug Administration, at no cost, to the providers who are required to offer opioid overdose
142-reversal drugs approved by the federal Food and Drug Administration under § 8–408 or §
143-19–310.3 of this article. Ch. 356 2023 LAWS OF MARYLAND
135+13–3103. 27
144136
145-– 4 –
137+ (a) The Department shall adopt regulations necessary for the administration of 28
138+the Program. 29
146139
147- (2) An entity required to offer an opioid overdose reversal drug approved
148-by the federal Food and Drug Administration under § 8–408 or § 19–310.3 of this article
149-may provide an opioid overdose reversal drug approved by the federal Food and Drug
150-Administration only if the opioid overdose reversal drug approved by the federal Food and
151-Drug Administration is provided by the Department.
140+ (b) The Department may: 30
152141
153- (3) THE DEPARTMENT SHALL , SUBJECT TO THE LIMIT ATIONS OF THE
154-STATE BUDGET , ALLOW AN ENTITY THAT IS PROVIDED WITH OPI OID OVERDOSE
155-REVERSAL DRUGS BY TH E DEPARTMENT UNDER THIS SUBSECTION TO CHOOSE THE
156-FORMULATION OR DOSAG E OF OPIOID OVERDOSE REVERSAL DRUGS APPRO VED BY
157-THE FEDERAL FOOD AND DRUG ADMINISTRATION WITH W HICH THE ENTITY IS T O
158-BE PROVIDED.
142+ (1) Collect fees necessary for the administration of the Program; 31
159143
160-Article – State Finance and Procurement
144+ (2) Authorize private or public entities to conduct education and training 32
145+on opioid overdose recognition and response that include: 33 4 HOUSE BILL 571
161146
162-7–331.
163147
164- (a) In this section, “Fund” means the Opioid Restitution Fund.
165148
166- (b) There is an Opioid Restitution Fund.
149+ (i) Education on recognizing the signs and symptoms of an opioid 1
150+overdose; 2
167151
168- (c) The purpose of the Fund is to retain the amount of settlement revenues
169-deposited to the Fund in accordance with subsection (e)(1) of this section.
152+ (ii) Training on responding to an opioid overdose, including the 3
153+administration of opioid overdose reversal drugs approved by the federal Food and Drug 4
154+Administration; and 5
170155
171- (h) (1) Expenditures from the Fund may be made only in accordance with the
172-State budget.
156+ (iii) Access to opioid overdose reversal drugs approved by the federal 6
157+Food and Drug Administration and the necessary supplies for the administration of the 7
158+opioid overdose reversal drugs; 8
173159
174- (2) For settlement funds received in accordance with the final distributor
175-agreement of July 21, 2021, with McKesson Corporation, Amerisource Bergen Corporation,
176-and Cardinal Health Incorporated, as amended, [or] the Janssen settlement agreement of
177-July 21, 2021, as amended , OR ANY OTHER OPIOID –RELATED COURT OR
178-ADMINISTRATIVE JUDGM ENT OR SETTLEMENT AG REEMENT INVOLVING TH E STATE
179-AND ONE OR MORE OF I TS POLITICAL SUBDIVI SIONS:
160+ (3) Develop guidance regarding the content of educational training 9
161+programs conducted by private or public entities; and 10
180162
181- (i) appropriations from the Fund in the State budget shall be made
182-in accordance with the allocation and distribution of funds to the State and its political
183-subdivisions:
163+ (4) Collect and report data on the operation and results of the programs. 11
184164
185- 1. as agreed on in the State–subdivision agreement of
186-January 21, 2022, as amended; OR
165+ (c) An individual is not required to obtain training and education on opioid 12
166+overdose recognition and response from a private or public entity under subsection (b) of 13
167+this section in order for a pharmacist to dispense an opioid overdose reversal drug approved 14
168+by the federal Food and Drug Administration to the individual. 15
187169
188- 2. REQUIRED UNDER ANY OT HER OPIOID –RELATED
189-COURT OR ADMINISTRAT IVE JUDGMENT OR SETT LEMENT AGREEMENT , OR ANY
190-SIMILAR AGREEMENT RE ACHED UNDER AN OPIOI D–RELATED COURT OR WES MOORE, Governor Ch. 356
170+ (d) (1) Subject to the limitations of the State budget, the Department shall 16
171+purchase and provide opioid overdose reversal drugs approved by the federal Food and 17
172+Drug Administration, at no cost, to the providers who are required to offer opioid overdose 18
173+reversal drugs approved by the federal Food and Drug Administration under § 8–408 or § 19
174+19–310.3 of this article. 20
191175
192-– 5 –
193-ADMINISTRATIVE JUDGM ENT OR SETTLEMENT AG REEMENT, INVOLVING THE STATE
194-AND ONE OR MORE OF I TS POLITICAL SUBDIVISION S; and
176+ (2) An entity required to offer an opioid overdose reversal drug approved 21
177+by the federal Food and Drug Administration under § 8–408 or § 19–310.3 of this article 22
178+may provide an opioid overdose reversal drug approved by the federal Food and Drug 23
179+Administration only if the opioid overdose reversal drug approved by the federal Food and 24
180+Drug Administration is provided by the Department. 25
195181
196- (ii) the Secretary of Health shall establish and administer a grant
197-program for the distribution of funds to political subdivisions of the State in accordance
198-with:
182+ (3) THE DEPARTMENT SHALL , SUBJECT TO THE LIMIT ATIONS OF THE 26
183+STATE BUDGET , ALLOW AN ENTITY THAT IS PROVIDED WITH OPI OID OVERDOSE 27
184+REVERSAL DRUGS BY TH E DEPARTMENT UNDER THIS SUBSECTION TO CHOOSE THE 28
185+FORMULATION OR DOSAG E OF OPIOID OVERDOSE REVERSAL DRUGS APPRO VED BY 29
186+THE FEDERAL FOOD AND DRUG ADMINISTRATION WITH W HICH THE ENTITY IS TO 30
187+BE PROVIDED. 31
199188
200- 1. the State–subdivision agreement of January 21, 2022, as
201-amended; OR
189+Article – State Finance and Procurement 32
202190
203- 2. THE REQUIREMENTS OF ANY OTHER
204-OPIOID–RELATED COURT OR ADM INISTRATIVE JUDGMENT OR SETTLEMENT
205-AGREEMENT , OR ANY SIMILAR AGREE MENT REACHED UNDER A N OPIOID–RELATED
206-COURT OR ADMINISTRAT IVE JUDGMENT OR SETT LEMENT AGREEMENT , INVOLVING
207-THE STATE AND ONE OR MORE OF ITS POLITICAL SUB DIVISIONS.
191+7–331. 33
208192
209- (3) The Attorney General shall identify and designate the controlling
210-version of any agreement or amendment described under paragraph (2) of this subsection.
193+ (a) In this section, “Fund” means the Opioid Restitution Fund. 34 HOUSE BILL 571 5
211194
212- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
213-October July 1, 2023.
214195
215-Approved by the Governor, May 3, 2023.
196+
197+ (b) There is an Opioid Restitution Fund. 1
198+
199+ (c) The purpose of the Fund is to retain the amount of settlement revenues 2
200+deposited to the Fund in accordance with subsection (e)(1) of this section. 3
201+
202+ (h) (1) Expenditures from the Fund may be made only in accordance with the 4
203+State budget. 5
204+
205+ (2) For settlement funds received in accordance with the final distributor 6
206+agreement of July 21, 2021, with McKesson Corporation, Amerisource Bergen Corporation, 7
207+and Cardinal Health Incorporated, as amended, [or] the Janssen settlement agreement of 8
208+July 21, 2021, as amended , OR ANY OTHER OPIOID –RELATED COURT OR 9
209+ADMINISTRATIVE JUDGM ENT OR SETTLEMENT AGREEMENT INVOLVING THE STATE 10
210+AND ONE OR MORE OF I TS POLITICAL SUBDIVI SIONS: 11
211+
212+ (i) appropriations from the Fund in the State budget shall be made 12
213+in accordance with the allocation and distribution of funds to the State and its political 13
214+subdivisions: 14
215+
216+ 1. as agreed on in the State–subdivision agreement of 15
217+January 21, 2022, as amended; OR 16
218+
219+ 2. REQUIRED UNDER ANY O THER OPIOID –RELATED 17
220+COURT OR ADMINISTRAT IVE JUDGMENT OR SETT LEMENT AGREEMENT , OR ANY 18
221+SIMILAR AGREEMENT RE ACHED UNDER AN OP IOID–RELATED COURT OR 19
222+ADMINISTRATIVE JUDGM ENT OR SETTLEMENT AG REEMENT, INVOLVING THE STATE 20
223+AND ONE OR MORE OF I TS POLITICAL SUBDIVI SIONS; and 21
224+
225+ (ii) the Secretary of Health shall establish and administer a grant 22
226+program for the distribution of funds to political subdivisions of the State in accordance 23
227+with: 24
228+
229+ 1. the State–subdivision agreement of January 21, 2022, as 25
230+amended; OR 26
231+
232+ 2. THE REQUIREMENTS OF ANY OTHER 27
233+OPIOID–RELATED COURT OR ADM INISTRATIVE JUDGMENT OR SETTLEMENT 28
234+AGREEMENT , OR ANY SIMILA R AGREEMENT REACHED UNDER AN OPIOID –RELATED 29
235+COURT OR ADMINISTRAT IVE JUDGMENT OR SETT LEMENT AGREEMENT , INVOLVING 30
236+THE STATE AND ONE OR MORE OF ITS POLITICAL SUB DIVISIONS. 31
237+
238+ (3) The Attorney General shall identify and designate the controlling 32
239+version of any agreement or amendment described under paragraph (2) of this subsection. 33
240+ 6 HOUSE BILL 571
241+
242+
243+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 1
244+October July 1, 2023. 2
245+
246+
247+
248+
249+
250+Approved:
251+________________________________________________________________________________
252+ Governor.
253+________________________________________________________________________________
254+ Speaker of the House of Delegates.
255+________________________________________________________________________________
256+ President of the Senate.